When is the right time to question a medical decision?
In May 2010 a finding of serious professional misconduct and the sanction of erasure was handed down by the GMC’s fitness to practise panel (the Panel) against Professor Walker-Smith (the appellant). On 7 March 2012 Mr Justice Mitting allowed the appellant’s appeal, handing down a judgment quashing the finding and sanction.
Professor Walker-Smith had a distinguished career in paediatric gastroenterology and from September 1995 practised as a Professor of Paediatric Gastroenterology at the Royal Free Hospital (the hospital).
In September 1996 a new research project was approved for registration by the hospital’s Ethics Committee. This was given the reference“172-96” by the committee. The appellant was named as the responsible consultant alongside W and M.
The project investigated the possible link between measles/rubella vaccination and enteritis and disintegrative disorder in children. Enteritis is a gastrointestinal condition characterised by, amongst other symptoms, pain, bloating, constipation and diarrhoea. Disintegrative disorder is a recognised but rare condition, distinct from autism, whereby normally developing children show marked behavioural changes and developmental regression after age two, often in association with bowel or bladder problems.
It is worth underlining the fact that the link to be investigated was between enteritis and disintegrative disorder and measles/rubella vaccination, not the link between autism and the MMR vaccination. However, the link between the latter was a developing view held by the appellant’s colleague, W and co-responsible consultant for project 172-96.
As part of project 172-96, children were to be admitted to the hospital for one week under the appellant’s care, during which time, with fully informed parental consent, they would undergo a number of investigations. These investigations involved sedation or general anaesthesia. Prior to approval being granted by the Ethics Committee, there was a query whether the investigations could be deemed “high risk” according to categorisations adopted by the British Paediatric Association. This guidance advised that it would be unethical to submit child subjects to more than minimal risk when the procedure offers no or a slight or very uncertain benefit to them. The Ethics Committee sought confirmation from the appellant on whether “the child would undergo this regimen even it if was not in a trial”.
In response, the appellant responded in writing in November 1996. He said that he and his team had so far investigated five children with gastrointestinal symptoms who also suffered from disintegrative disorder, a “devastating condition” that left children and their parents with a “hopeless prognosis”. He wrote of the clinical need basis of their admittance by reference to a measurable benefit achieved by being able to establish a diagnosis in this “seriously under-investigated condition” and commencing on a therapeutic regime. The appellant made it clear that the children involved would be having these investigations whether or not approval was granted for project 172-96.
Project 172-96 was approved on 18 December 1996, subject to conditions including a condition that only patients enrolled after that date be considered to be in the trial.
Between 21 July 1996 and 16 February 1997 eleven children were admitted to the hospital for investigation under the appellant and his team. The case histories of those 11 children were later summarised in a paper published in The Lancet in February 1998 of which the appellant, together with W, was listed as a senior author. At a press conference convened to coincide with publication of that paper, W stated publicly his view that he could no longer support the giving of MMR vaccine. At the time, W’s views attracted wide publicity and adversely affected the take up of the MMR vaccine.
The appellant had not been present at that press conference and had previously shared his view with W that in the absence of more conclusive evidence he could not lend his support to the linking of MMR and autism. Mitting J described the appellant’s view on the claimed link as “agnostic or cautious”. The appellant published press release shortly after, expressing his support for the “present public health policy concerning MMR”.
The GMC case was that in relation to the eleven children who had been the subject of The Lancet paper, they had been inappropriately subjected to a programme of research pursuant to project 172-96 without approval because it had taken place prior to approval being given, or because the children’s condition had not met the selection criteria, or because they had been carried out in breach of the conditions of approval. The appellant’s case was that he was conducting clinically appropriate practice separate from project 172-96 (see reference to the November 1996 letter) which therefore did not require Ethics Committee approval.
The GMC also alleged that the appellant knew that the reporting of a temporal link between the syndrome described and MMR vaccination had major public health implications and would attract intense public and media interest. Consequently, as a senior author, the appellant had a duty to ensure that the factual information in the paper and any information provided by him in response to queries was true and accurate.
A key question was to consider the distinction between medical practice and research. Both sides accepted a basic distinction summarised in Mitting J’s judgment: “the aim of medical practice is to benefit the individual patient; the aim of research is to improve the stock of knowledge for the benefit of patients generally”. The GMC’s case had been that the appellant had been undertaking research, either without realising that he was doing so, or after lying to the Ethics Committee about his true intentions. The GMC did not pursue the latter argument on appeal. The Royal College of Physicians’ guidance on the subject of the distinction between research and medical practice emphasised the primary intent of the clinician carrying out the research/medical practise. The Panel’s determination that investigations into the eleven children had been carried out pursuant to project 172-96 “in the light of all the available evidence” was fundamentally flawed where it had not addressed itself to the intent of the appellant or alternatively whether he had lied to the Ethics Committee. In addition, findings in relation to each of the eleven children had been wrong in a number of instances.
In respect of ten of those children, both sides had led expert evidence to support their case, two for each party. In relation to three of those experts (both of the GMC experts and one for the appellant) various criticisms were made by the Panel ranging from inadequate expertise to lack of objectivity/independence. Mitting J commented that “it was a striking feature of the panel’s decision that it expressed no view about the expertise and objectivity of the experts; and even more striking that, when their views were in conflict, it expressed no conclusion about which of them it preferred. This is a serious weakness in its reasoning” [para 23]. He went on to comment “In no individual case in which the panel made a finding adverse to Professor Walker-Smith did it address the expert evidence led for him, except to misstate it” [para 150].
Although Mr Justice Mitting noted that “there is now no respectable body of opinion which supports [the] hypothesis, that MMR vaccine and autism/enterocolitis are causally linked”, the case has attracted some attention outside of ordinary legal press, presumably because it revisits this controversial and emotive topic. From a practitioners perspective, aside from the investigation into the definition of “research” and where it can be said to be distinct from, if overlapping with clinically indicated practice, the subject of expert opinion evidence is also live. In a month where a report by the University of Central Lancashire has found that one fifth of the psychological expert witnesses instructed to give evidence in family cases are “inadequately qualified” the potential pitfalls of expert evidence are under the spotlight again, albeit for slightly different reasons as those identified by the University of Central Lancashire report.
This case reminds practitioners once again of the practical difficulties in seeking to secure an expert where they are being asked to comment on an extremely niche field. It is increasingly likely that, as with the appellant’s expert witness, it can be said that “by reason of long professional association”, at the senior end of any profession, objectivity may be lacking even where the expert evidence is given in good faith as objective and independent evidence. Additionally, leaving aside the objectivity question, with the advance of medical knowledge, arguably particular fields of expertise are ever narrowing, making it harder and harder to find experts who can comment at all.
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